3- Salient Features 36C24822Q1770.pdf

Salient Characteristics – Virtual Reality Intraocular Surgery Training Simulator

• Simulator must be able to be equipped with a patient model head for either cataract or vitreoretinal surgery training and an according set of handpieces that can be inserted through incisions in the model eye.

• Simulator patient model head must be able to be operated on from a temporal or superior position

• Simulator must include a handheld light source or a chandelier illumination and scleral indentation for use during simulation of the posterior segment environment.

• Simulator must have a binocular microscope featuring mechanical and optical systems, with focus and zoom controlled using a foot pedal.

• Simulator must be able to integrate a binocular indirect opthalmomicroscope and a stereoscopic diagonal inverter hardware mimic for posterior segment surgery training.

• Simulator must include virtual cataract instruments such as forceps, visco cannula, cystotome, and phaco probes that can be assigned to the handpieces using a touch screen.

• Simulator must have an OR machine interface and a two-axis foot pedal to control fluidics.

• Simulator must include preinstalled courseware that starts with basic skills, with didactically structured courses.

• Simulator must include cataract courseware that is organized into the following tiers of ascending difficulty:

o Tier CAT-A: The CAT-A tier uses abstract scenarios to train basic microsurgical skills, such as instrument navigation in the anterior chamber, tremor control, fine motor dexterity, and proper microscope use.

o Tier CAT-B: In the CAT-B tier, isolated steps of cataract surgery are trained following abstract instrument handling tasks. Trainees will practice first steps in capsulorhexis, lens segmentation, lens removal, and intraocular lens insertion in a simulated surgical environment.

o Tier CAT-C: The CAT-C tier refines the acquired cataract skills through more challenging scenarios: trainees practice advanced surgery techniques, such as vertical chopping or insertion of a toric IOL, and perform multistep cataract procedures, for example, the complete phaco divide and conquer technique.

o Tier CAT-D: The CAT-D tier offers difficult cataract surgery cases under demanding conditions, such as high capsular tensions or weak zonules. Trainees will be challenged by randomized tasks and complications, such as posterior capsule rupture, requiring them to adapt to the surgical scenario quickly

• Simulator must include vitreoretinal courseware that is organized into the following tiers of ascending difficulty:

o Tier VRT-A: The VRT-A tier uses abstract scenarios to train basic surgical skills, such as instrument navigation in the vitreous and using the non-dominant hand. Trainees will also learn to visualize the vitreous through efficient use of the microscope, auxiliary optics, and light source.

o Tier VRT-B: In the VRT-B tier, different vitreoretinal surgery steps will be trained separately; following abstract instrument handling tasks, trainees will practice first steps in peeling and removing membranes, using the endolaser, and setting the vitrectomy machine for different purposes.

o Tier VRT-C: The advanced VRT-C tier refines already acquired surgery skills by training multi-step vitreoretinal procedures under increasingly demanding conditions, such as retinal detachment treatment. Enhanced proficiency with the non-dominant hand is required to peel highly adherent membranes

• Simulator must feature visual and auditive guidance to support trainees such as graphical elements indicating the optimal rhexis diameter, injection speed, or the distance of the instrument to lens and cornea, with additional text messages to point out surgical mistakes.

• Simulator must include optional online courses that may be intertwined with the simulator curriculum.

• Simulator must provide trainees with a detailed performance summary at the end of each task that includes various parameters relating to instrument and microscope handling, surgical efficiency and tissue treatment recorded by the system.

• Simulator must include the ability for educators to monitor their residents training progress via a web portal, and the ability for the educators to manage their trainees’ courses accordingly.

• Simulator courseware must utilize scoring gates to ensure reliability of the performance level, only allowing trainees to advance through assigned courses after having met a required minimum score three times in a row.

• Simulator must include a cataract challenge course that mimics the conditions of real surgery where trainees have to perform complete cataract procedure in sequential order every 60 minutes of training time, with only one attempt at each cataract step and a limited window of 15 minutes.